Lonza to support Pionyr Immunotherapeutics' oncology drug development
The CDMO will provide cell line development, process development, drug substance and drug product manufacturing for Pionyr’s monoclonal antibody candidate
Pionyr Immunotherapeutics and Lonza have entered into a collaboration to manufacture Pionyr’s monoclonal antibody candidate intended for oncology indications.
Lonza will provide a gene to IND program tailored to suit the specific requirements of Pionyr’s products. The scope will include cell line development, process development, supply chain simplification and de-risking, as well as drug substance manufacturing at Lonza’s Visp (Switzerland) site, and drug product manufacturing at Stein (Switzerland) to help Pionyr advance their programs into clinical development and testing.
The cell line development to drug product program will begin in Q2 2021. The cGMP batches of drug substance and drug product are expected to be completed early next year.
Developing a high-producing, stable cell line represents a critical path activity for the production of large quantities of therapeutic antibodies. This collaboration will allow Pionyr to take advantage of the Beacon platform, which can screen and monitor thousands of clones at once and in a short time, thereby optimizing and streamlining the cell line construction process.
The collaboration will initially focus on Pionyr’s third program named PY265, which is directed against an undisclosed target. Similar to Pionyr’s PY314 and PY159 programs (targeting TREM2 and TREM1, respectively), this third program is anticipated to be first-in-class and will have a distinct mechanism of action from other myeloid-directed therapeutics currently in development.
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